Drug Evaluation Committee A Study Toward the Use of Clinical Trial Methods that Do Not Depend on Visits to Medical Institutions - A Guide for Introduction in Japan - (Japanese only)
Clinical Evaluation Subcommittee
August 2021
With the spread of the concept of Patient Centricity and the use of digital technology in drug development, clinical trial methods that do not rely on visits to medical institutions are attracting attention. This new clinical trial method is called Decentralized Clinical Trials (DCT), which decentralizes the activities related to clinical trials conducted at medical institutions and allows patients to participate in clinical trials without having to make regular visits to the hospital.
Based on the findings of Task Force 3 of the Clinical Evaluation Subcommittee in FY2020, Task Force 3 of the Clinical Evaluation Subcommittee in FY 2019 prepared "Study on the Use of Clinical Trial Methods that Do Not Depend on Visits to Medical Institutions - A Guide for Introduction in Japan -" has been prepared.
We hope that this deliverable will help not only pharmaceutical companies but also many other parties involved in clinical trials to consider DCTs in concrete terms and help DCTs to spread in Japan.
2020 Clinical TF3_Subcommittee Document (1.1MB)
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